Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene
Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.
The only sunscreen products impacted are aerosol products, specifically:
NEUTROGENA® Beach Defense® aerosol sunscreen,
NEUTROGENA® Cool Dry Sport aerosol sunscreen,
NEUTROGENA® Invisible Daily™ defense aerosol sunscreen,
NEUTROGENA® Ultra Sheer® aerosol sunscreen, and
AVEENO® Protect + Refresh aerosol sunscreen.
Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of All Sterile Compounded Drug Products Due to A Lack of Sterility Assurance
Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.
The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3 inch by 3 inch white box. Products were distributed nationwide to both customers and/or medical facilities.
Food & Beverages Recalls
Give and Go Prepared Foods (U.S.A.) Corp. Conducts Voluntary Recall of Certain Muffin Products Due to Possible Health Risk
Give and Go Prepared Foods (U.S.A.) Corp. announced today a voluntary nationwide recall of certain muffin products due to the potential for the products to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Lipari Foods of Warren, Michigan is recalling 86 cases of Troyer Manufacturing Backroad Country Dried Apricots because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
Backroad Country Dried Apricots were distributed to Alabama, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, North Carolina, Ohio, Pennsylvania, Tennessee, Utah, Virginia, Wisconsin, & West Virginia to retail locations.
The Dried Apricots are in a clear, plastic-film bag with the Backroad Country Label on the front. Each bag is 9 ounces filled with orange-colored dried apricots that can be seen through the bag. Affected lot code of the product is 440021117 with an expiration date of 12/2021.
Alpha Male Plus Issues Voluntary Nationwide Recall of Alpha Male Plus Male Enhancer Due to the Presence of Undeclared Tadalafil
Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Alpha Male Plus has not received any reports of adverse events related to this recall.
BrightFarms Announces Voluntary Recall of Packaged Salad Greens Sold in Illinois, Wisconsin, Iowa and Indiana
BrightFarms today initiated a voluntary recall of packaged salad greens produced in its Rochelle, Illinois (Ogle County) greenhouse farm sold in Illinois, Wisconsin, Iowa and Indiana because it has the potential to be contaminated with Salmonella.
The affected BrightFarms-branded products were sold by the following retailers:
- Illinois: Mariano's Fresh Markets, Walmart (select stores), Strack Van Till, Sullivan's Foods, Caputo's, Jewel-Osco
- Wisconsin: Pick 'n Save, Metro Market, Copps, Tadych's, Walmart (select stores)
- Iowa: Walmart (select stores)
- Indiana: Strack Van Till
Additional retailers may be affected.
5000 YEARS FOODS, INC. of CHICAGO, ILLINOIS is recalling SLICED CABBAGE KIMCHI, WHOLE CABBAGE KIMCHI, JULRADO WHOLE CABBAGE KIMCHI, JULRADO SLICED CABBAGE KIMCHI, NO MSG WHOLE CABBAGE KIMCHI, NO MSG SLICED CABBAGE KIMCHI, NO MSG JULRADO WHOLE CABBAGE KIMCHI, NO MSG JULRADO SLICED CABBAGE KIMCHI, WHITE KIMCHI, BABY NAPA KIMCHI because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.